Rarely, in patients treated for asthma, serious (sometimes fatal) asthma-related breathing problems have occurred with the use of long-acting inhaled beta agonists (such as salmeterol). Because formoterol is similar to salmeterol, it may also cause these problems. Therefore, in patients with asthma, this drug should only be prescribed when one long-term medication (such as inhaled corticosteroids) does not control breathing problems or when more than one long-term medication is clearly needed to control breathing problems. Formoterol must not be used alone to treat asthma. Before using this medication, it is important to learn how to use it properly. Discuss the risks and benefits of treatment with this medication with your doctor.
Once asthma symptoms are controlled, if possible, your doctor may stop treatment with formoterol and continue only your other asthma medications (such as inhaled corticosteroids). Follow your doctor's directions carefully.Who should not take Formoterol Fumarate Capsule, With Inhalation Device?
Formoterol is a long-acting bronchodilator used as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It should only be used long-term if your asthma symptoms are not controlled by your other asthma medications (such as inhaled corticosteroids). Formoterol must not be used alone to treat asthma. (See also Warning section.) It works in the airways by relaxing muscles and opening air passages to improve breathing. Controlling symptoms of breathing problems can decrease time lost from work or school.
This medication should not be used for a severe/sudden asthma attack. For sudden attacks of asthma, use your quick-relief inhaler as prescribed. This medication is not a substitute for inhaled or oral corticosteroids (e.g., beclomethasone, fluticasone, prednisone). This medication should be used along with another controller-type asthma medication (such as inhaled corticosteroids). However, it should not be used with other long-acting beta-agonist inhalers (such as arformoterol, salmeterol) because doing so may increase your risk for side effects.
It is recommended that children and teenagers, who need to use formoterol to treat their asthma, should use a combination formoterol/budesonide product. Check with your child's doctor to see if this product is the right product for your child.
Formoterol comes in a capsule. Do not swallow these capsules by mouth. Inhale the contents of the capsule by mouth using the inhaler device, usually one capsule twice daily (morning and evening) or as directed by your doctor. The two doses should be about 12 hours apart. Formoterol must always be used with its own special inhaler device. Use the new inhaler device that you get each time you refill your formoterol prescription. Always discard your old inhaler device. Do not use a "spacer" device with the inhaler.
Leave the capsule sealed in the foil packet until just before use. Wash and completely dry hands before touching the capsules. Be sure to inhale rapidly and deeply through the mouthpiece when using this drug. Open the inhaler after use. Check that the capsule is empty. If it is not empty, close the inhaler and repeat. Do not exhale into the inhaler.
If you are using this medication to prevent exercise-induced breathing problems (EIB), it should be used at least 15 minutes before exercising. Do not use any more doses of formoterol for the next 12 hours. If you are already using formoterol twice daily, do not use any more doses for EIB.
Your asthma must be stable (not worsening) before you start treatment with formoterol. Consult your doctor for more details.
If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.
Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.
Using too much formoterol or using it too often may result in a decrease in drug effectiveness and an increase in serious side effects. Do not use more than the recommended dosage or take this drug more often than prescribed. Do not stop or decrease the dose of other asthma medications (e.g., inhaled corticosteroids such as beclomethasone) without your doctor's approval. If you are using short-acting bronchodilators on a regular schedule (such as every six hours), you should stop taking them while using this drug.
Seek immediate medical attention if you notice any of the following signs of worsening asthma: the usual doses of your asthma medications no longer control symptoms, your quick-relief inhaler is less effective, or you need to use the quick-relief inhaler more often than usual (e.g., more than 4 puffs per day or more than 1 inhaler every 8 weeks). Do not increase your dose of formoterol in this situation.
When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor right away if this medication stops working well.
Shakiness (tremor), nausea, headache, dizziness, nervousness, dry mouth, stomach upset, tiredness, trouble sleeping, or hoarseness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: dizziness, rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.
Rarely, formoterol can cause a worsening of breathing problems (paradoxical bronchospasm) that may be life-threatening. If this occurs, immediately seek medical attention.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking formoterol, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (such as albuterol, arformoterol, metaproterenol, salmeterol); or to sympathomimetic drugs (e.g., epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures, diabetes, metabolism problems (e.g., ketoacidosis), swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).
Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using formoterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using formoterol safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
See also Uses section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
This medication will not work and may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: chest pain, fast/irregular heartbeat, severe nervousness, severe dizziness, fainting, seizures, severe muscle cramps.
Laboratory and/or medical tests (e.g., blood pressure, heart rate, EKG, pulmonary function) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from heat and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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